RISPERIDONE TABLETS

Země: Kanada

Jazyk: angličtina

Zdroj: Health Canada

Aktivní složka:

RISPERIDONE

Dostupné s:

RANBAXY PHARMACEUTICALS CANADA INC.

ATC kód:

N05AX08

INN (Mezinárodní Name):

RISPERIDONE

Dávkování:

0.5MG

Léková forma:

TABLET

Složení:

RISPERIDONE 0.5MG

Podání:

ORAL

Jednotky v balení:

10/1000

Druh předpisu:

Prescription

Terapeutické oblasti:

ATYPICAL ANTIPSYCHOTICS

Přehled produktů:

Active ingredient group (AIG) number: 0124332007; AHFS:

Stav Autorizace:

APPROVED

Datum autorizace:

2009-08-19

Charakteristika produktu

_Page 1 of 53 _
PRODUCT MONOGRAPH
PR
RISPERIDONE TABLETS
(risperidone)
(house standard)
0.25, 0.5, 1, 2, 3 and 4 mg
Antipsychotic Agent
Ranbaxy Pharmaceuticals Canada Inc.
2680 Matheson Blvd. East, Suite 200
Mississauga, Ontario L4W 0A5
Date of Preparation:
August 18, 2009
Submission Control No: 132004
_Page 2 of 53 _
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL
INFORMATION……………………………………... 3
SUMMARY PRODUCT
INFORMATION……………………………………………….. 3
INDICATIONS AND CLINICAL
USE…………………………………………………… 3
CONTRAINDICATIONS……………………………………………………………….….
4
WARNINGS AND PRECAUTIONS
………………………………………………………4
ADVERSE
REACTIONS…………………………………………………………………..
12
DRUG
INTERACTIONS…………………………………………………………………..
21
DOSAGE AND
ADMINISTRATION……………………………………………………..
24
OVERDOSAGE……………………………………………………………….……………27
ACTION AND CLINICAL
PHARMACOLOGY………………………………………….
27
STORAGE AND
STABILITY…………………………………………...………………..
30
DOSAGE FORMS, COMPOSITION AND
PACKAGING……………........................…. 30
PART II: SCIENTIFIC
INFORMATION………………………………………………...……
32
PHARMACEUTICAL
INFORMATION…………………………………………………..
32
CLINICAL
TRIALS……………………………………………………........................…..
33
DETAILED
PHARMACOLOGY………………………………………........................….
36
TOXICOLOGY…………………………………………………………........................….
38
REFERENCES…………………………………………………………........................…